Radiopaque and septum-based indicators for a multi-lumen implantable port

ABSTRACT

An implantable multi-lumen access port including indicators for ascertaining characteristics of the port is disclosed. In one embodiment, the access port comprises a housing that defines a first reservoir and a second reservoir. A first septum and second septum are respectively coupled with the housing to provide selective access to the first and second reservoirs. Each septum includes a plurality of protrusions defined about a periphery thereof that are palpable after implantation of the port in a patient to determine a relative position of the first septum with respect to the second septum. A radiographically observable indicator is also included on a base of the housing, so as to provide information relating to a characteristic of the dual-lumen port, such as suitability for power injection of fluids. The indicator in one embodiment includes a substantially rigid radiopaque component.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Nos. 60/986,246, filed Nov. 7, 2007, and entitled “SeptumIdentifying Orientation in a Multi-Lumen Port,” 60/986,247, filed Nov.7, 2007, and entitled “Radiopaque Indicators for Implantable Ports,” and61/110,507, filed Oct. 31, 2008, and entitled “Radiopaque andRadiographically Discernible Indicators for an Implantable Port,” all ofwhich are incorporated herein by reference in their entireties.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toan implantable multi-lumen access port including indicators forascertaining characteristics of the port. In one example embodiment, theaccess port comprises a housing that defines a first reservoir and asecond reservoir. A first septum and second septum are respectivelycoupled with the housing to provide selective access to the first andsecond reservoirs.

Each septum includes a plurality of protrusions defined about aperiphery thereof that are palpable after implantation of the port in apatient to determine a relative position of the first septum withrespect to the second septum.

A radiographically observable indicator is also included on a base ofthe housing, so as to provide information relating to a characteristicof the dual-lumen port, such as suitability for power injection offluids. The indicator in one embodiment includes a substantially rigidradiopaque component. In another embodiment, the indicator is defined asa recess in a port including a radiopaque material, such as titanium,for example.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify embodiments of the disclosure, a more particulardescription will be rendered by reference to specific embodimentsthereof that are illustrated in the appended drawings. It is appreciatedthat these drawings depict only typical embodiments of the invention andare therefore not to be considered limiting of its scope. The inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a perspective view of an example embodiment of an implantableport including a first septum and a second septum;

FIG. 2 is a schematic illustration of an embodiment of an implantableport including palpation features arranged in one example septumidentification pattern;

FIG. 3 is a schematic illustration of an embodiment of an implantableport including palpation features arranged in another septumidentification pattern;

FIG. 4 is a perspective view of another embodiment of an implantableport that includes a first septum and a second septum, and furtherincludes a ridge between the first and second septa;

FIG. 5 is a top view of an implantable port that includes a first septumand a second septum, a ridge between the first and second septa, and ahousing contour configured according to one embodiment;

FIG. 6 is a schematic illustration of an implantable port includingpalpation features arranged according to one embodiment;

FIG. 7 is a schematic illustration of an implantable port includingpalpation features arranged according to one embodiment;

FIG. 8 is a schematic illustration of an implantable port includingpalpation features arranged according to one embodiment;

FIG. 9 is a schematic illustration of an implantable port includingpalpation features arranged according to one embodiment;

FIG. 10 is a top view of an implantable port that includes a firstseptum and a second septum, a housing contour, and a plurality ofprotrusions disposed in proximate relation to the first and secondsepta, according to one embodiment;

FIG. 11 is a bottom view of the implantable port of FIG. 1, depictingfeatures of a radiopaque indicator according to one example embodiment;

FIG. 12A is an exploded view of the implantable port of FIG. 1;

FIG. 12B is an assembled bottom perspective view of the implantable portof FIG. 1;

FIG. 13 is a bottom perspective view of an implantable port including aradiopaque indicator according to one embodiment;

FIG. 14 is a schematic illustration an image of the implantable port ofFIG. 13 that can be obtained by imaging techniques;

FIG. 15 is a schematic illustration, such as that of FIG. 14, of anotherembodiment of an implantable port;

FIG. 16 is a bottom view of another embodiment of an implantable port;

FIG. 17 is a bottom view of another embodiment of an implantable port;

FIG. 18 is a bottom view of another embodiment of an implantable port;

FIG. 19 is a top view of a radiographic indicator configured inaccordance with one embodiment;

FIG. 20 is a top view of a radiographic indicator configured inaccordance with one embodiment;

FIG. 21 is a top view of a radiographic indicator configured inaccordance with one embodiment;

FIG. 22 is a top view of a radiographic indicator configured inaccordance with yet another embodiment;

FIG. 23 is a bottom perspective view of an implantable port including anindicator according to one embodiment; and

FIGS. 24A and 24B are cross sectional views of an edge of an indicator,such as the indicator shown in FIG. 12A.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the invention, and are not limiting of the presentinvention nor are they necessarily drawn to scale.

FIGS. 1-22 depict various features of embodiments of the presentinvention, which are generally directed to ports, also referred toherein as access ports, for implantation into the body of a patient. Insome situations, it can be desirable to facilitate access to thevasculature of a patient for purposes of blood withdrawal and/orinfusions, such as when the patient is ill and may repeatedly undergosuch procedures. In some instances, a catheter is situated within ablood vessel of the patient and a port is placed in fluid communicationwith the catheter. Accordingly, infusions and blood withdrawals may bemade via the port, rather than directly through the wall of a bloodvessel. In some situations, it can be advantageous to implant the portwithin the patient.

Reference is first made to FIG. 1, wherein an implantable port 10 isdisclosed as configured in accordance with one example embodiment. Asshown, the port 10 includes a housing 20 that defines a first reservoir31 and a second reservoir 32. A stem 35, which extends from the housing20, is configured for coupling with a dual lumen catheter 36. The stem35 defines a first fluid passageway 41 configured to couple with a firstlumen 37 of the catheter and a second fluid passageway 42 configured tocouple with a second lumen 38 of the catheter. The first and secondfluid passageways 41, 42 are in fluid communication with the first andsecond reservoir 31, 32, respectively.

In the present embodiments, the port 10 includes a first septum 51 and asecond septum 52. The first septum 51 is coupled with the housing 20 andis configured to provide selective communication with the firstreservoir 31. For example, the first septum 51 includes an elastomericmaterial capable of being punctured by a needle, for example, a Huberneedle, and substantially resealing upon removal of the needle.Similarly, the second septum 52 provides selective communication withthe second reservoir 32.

According to the present embodiment, the first septum 51 defines aplurality of palpation features, such as protrusions 71A, 71B, 71C.Similarly, the second septum 52 defines a plurality of protrusions 72A,72B, 72C. In the illustrated embodiment, the protrusions 71A, 71B, 71Cdefine end points, or vertices, of a triangle, for example, anequilateral triangle, and are spaced at approximately regular intervalsaround the periphery of the first septum 51. Similarly, the protrusions72A, 72B, 72C define end points, or vertices, of a triangle, forexample, an equilateral triangle, and are spaced at approximatelyregular intervals around the periphery of the second septum 52. Theprotrusions 71A, 71B, 71C and 72A, 72B, 72C extend outward from theseptum surface such that the protrusions define a portion of top profileof the port 10 from the perspective of the port as shown in FIG. 1.

The port 10 is configured to be implanted subcutaneously within apatient. Accordingly, when the catheter 36 is coupled with the stem 35and inserted in a blood vessel of the patient, fluid communication canbe established with the blood vessel via one of the first and secondreservoirs 31, 32, such as by an infusion needle inserted through acorresponding one of the septa 51, 52.

As seen in FIG. 1, each protrusion 71A, 71B, 71C and 72A, 72B, 72C isshaped to define a substantially hemispherical shape to provide a smoothsurface and to avoid irritating body tissue proximate the port implantedlocation. In other embodiments, though, the shape, size, number, andplacement of the palpation features can be modified from what isexplicitly shown and described herein in order to suit a particularneed. For instance, the protrusions can define a geometric or oval shapein one example. In one embodiment, the protrusions extend a distance ofabout 0.1 inch above the surface of the corresponding septum 51, 52,though other size dimensions are of course possible. The protrusions71A, 71B, 71C and 72A, 72B, 72C are integrally formed with thecorresponding septum 51 or 52, in one embodiment.

The palpation features, i.e., protrusions 71A, 71B, 71C and 72A, 72B,72C, of the first and second septa 51, 52 can permit a clinician toproperly identify the number of septa 51, 52 included in the port 10, aswell as the location and orientation of the desired septa, bothgenerally and with respect to one another, in preparation for a givenprocedure (e.g., insertion of an infusion needle into a particularseptum). For example, in many embodiments, when the port 10 is implantedsubcutaneously in a patient, the clinician cannot visually distinguishthe location of the first septum 51 from that of the second septum 52,especially for ports made from radio-translucent materials, which arenot sufficiently imaged radiographically. The clinician can instead feelor palpate the protrusions 71A, 71B, 71C and 72A, 72B, 72C through theskin to determine the general orientation of the port 10, the locationthe septa 51, 52, and/or to distinguish the location of one septum fromthat of the other. In one embodiment, the palpation protrusions furtherindicate suitability of the port for high fluid flow rate and/or highfluid pressure flow therethrough, such as power injection. These andother characteristics of the port can be indicated by the e protrusionsdescribed herein.

In many instances, a clinician has a need to properly identify thedesired septum 51, 52. For example, in some instances, it can beundesirable for the clinician to mistakenly puncture the same septumtwice when the clinician's intent is to use each septum separately. Itcan also be undesirable for the clinician to mistakenly fail to punctureeither septum and miss the port entirely. Accordingly, the protrusions71A, 71B, 71C and 72A, 72B, 72C are arranged in present embodiments inan identification pattern to reduce the likelihood of clinicianconfusion and/or error when identifying the location and/or orientationof the septa 51, 52.

FIG. 2 is a schematic illustration of an embodiment of the port 10having protrusions 71A, 71B, 71C and 72A, 72B, 72C arranged in a firstseptum identification pattern 100. In the illustrated embodiment, theidentification pattern 100 includes a plurality of sub-patterns 105A,105B, 105C. Each sub-pattern 105A, 105B, 105C substantially defines atriangular shape. Each set of protrusions 71A, 71B, 71C and 72A, 72B,72C separately defines one of the sub-patterns 105A, 105B, respectively,and the protrusions 71A of the first septum 51 and the protrusions 72B,72C of the second septum 52 cooperate to define a third sub-pattern105C.

FIG. 3 is a schematic illustration of an embodiment of the port 10having protrusions 71A, 71B, 71C and 72A, 72B, 72C arranged in a secondseptum identification pattern 110. In detail, the protrusions 71A, 71B,71C define an equilateral triangle sub-pattern 115A bisected by a longaxis 90 of the port 10 (see also FIG. 1). Similarly, the protrusions72A, 72B, 72C define an equilateral triangle sub-pattern 115B oppositelypositioned with respect to the triangle defined by the protrusions 71A,71B, 71C and which is also bisected by the port long axis 90.

A perimeter or outline of the pattern 110 defines a pattern that canreadily assist a clinician to determine a characteristic of the septa51, 52 with respect to the one another. In particular, the pattern canassist a clinician in distinguishing the relative locations of the septa51, 52. For example, the opposing edges, defined by the protrusions 71A,71B and 72B, 72C, respectively, of the pattern 110 can help a clinicianto determine that more of the surface areas of the septa are between theopposing edges of the pattern than outside of the opposing edges. Inaddition, the pattern 110 does not include any sub-patterns that areconfusingly similar to the triangular sub-patterns 115A, 115B. Inanother implementation, the pattern 110 can assist a clinician indetermining a general orientation of the port 10 as implanted within thepatient.

FIG. 4 depicts another embodiment wherein palpation features areincluded on an implantable port. In particular, a port 210 includes ahousing 20 that defines a ridge 220 between the septa 51, 52. As before,the first septum 51 defines a plurality of palpation features includingprotrusions 71A, 71B, 71C, while the second septum 52 defines aplurality of palpation features including protrusions 72A, 72B, 72C. Theprotrusions 71A, 71B, 71C and 72A, 72B, 72C are arranged as opposingequilateral triangles in mirror-image to one another, similar to thepattern 110 shown in FIG. 3. The ridge 220 can further aid indistinguishing the locations of the septa 51, 52.

FIG. 5 depicts another embodiment wherein palpation features areincluded on an implantable port. In particular, a port 310 includes ahousing 20 that defines a ridge 325 between the septa 51, 52. As before,the first septum 51 defines a plurality of palpation features includingprotrusions 71, while the second septum 52 defines a plurality ofpalpation features including protrusions 72. The protrusions 71 and 72are arranged as opposing equilateral triangles, similar to the pattern110 shown in FIG. 3. The ridge 325 can further aid in distinguishing thelocations of the septa 51, 52. Note that the housing defines arelatively more contoured outline than in the embodiments shown in FIGS.1 and 4.

FIGS. 6-9 depict further examples of palpation feature configurationsfor the implantable port, according to example embodiments. FIG. 6 showstwo oppositely positioned protrusions 171A, 171B included on theperiphery of the septum 51, and two similarly positioned protrusions172A, 172B included on the periphery of the septum 52. The protrusions171A, 171B and 172A, 172B are positioned at about 0 and 180 degree“compass” positions on their respective septa 51, 52, though it isappreciated that the respective positions of the protrusions can bemodified from what is shown here.

FIG. 7 shows four equally spaced protrusions 271A, 271B, 271C, 271Dincluded on the periphery of the septum 51, and four equally spacedprotrusions 272A, 272B, 272C, 272D included on the periphery of theseptum 52. The protrusions 271A, 271B, 271C, 271D and 272A, 272B, 272C,272D are positioned at about 0, 90, 180, and 270 degree compasspositions on their respective septa 51, 52, though it is appreciatedthat the respective positions of the protrusions can be modified fromwhat is shown here.

FIG. 8 shows four equally spaced protrusions 371A, 371B, 371C, 371Dincluded on the periphery of the septum 51, and two equally spacedprotrusions 372A, 372B included on the periphery of the septum 52. Theprotrusions 371A, 371B, 371C, 371D are positioned at about 0, 90, 180,and 270 degree compass positions on the septum 51, while the protrusions372A, 372B are positioned at about 90 and 180 degree compass positionson the septum 52, though it is appreciated that the respective positionsof the protrusions can be modified from what is shown here.

FIG. 9 shows three equally spaced protrusions 471A, 471B, 471C includedon the periphery of the septum 51, and three equally spaced protrusions472A, 472B, 472C included on the periphery of the septum 52. Theprotrusions 471A, 471B, 471C and 472A, 472B, 472C are positioned todefine vertices of imaginary equilateral triangles on their respectivesepta 51, 52 such that the bases of each triangle face one another todefine a septum identification pattern 480.

FIG. 10 depicts yet another embodiment wherein palpation features areincluded on an implantable port. In particular, a port 510 includes ahousing 20 defining two apertures into which the septa 51, 52 areinserted, as before. A plurality of protrusions 571 are included on anddefined by the port housing 20 proximately adjacent the periphery of thesepta 51, 52. The protrusions 71 and 72 define vertices of opposingequilateral triangles, similar to the pattern 110 shown in FIG. 3. Thusit is noted that the palpation features can be included on either areasof the port in addition to the septa. Note further that the housingdefines a relatively more contoured outline than in the embodimentsshown in FIGS. 1 and 4, thus illustrating that the shape of the housing20 can vary from what is described herein.

As the embodiments above make clear, the number, size, position, andshape of the palpation features can be modified while residing withinthe scope of embodiments of the present invention. In addition to theabove embodiments, it is appreciated, for example, that the protrusionscan define sub-patterns other than equilateral triangles, includingacute triangles, obtuse triangles, etc. Additionally, one or more, twoor more, three or more, four or more, five or more, etc. protrusionscould be used, and need not be arranged about the periphery of thesepta. In various embodiments, the port comprises two or more septa withprotrusions extending therefrom. The protrusions can define a variety ofdifferent shapes, and may be sized differently. Thus, the foregoingexamples are merely illustrative in nature.

Reference is now generally made to FIGS. 11-22 in describing variousdetails regarding further embodiments of the present invention. As hasbeen described, in many implementations, it can be desirable todetermine information regarding an access port subsequent toimplantation in the body of a patient. For example, in some embodiments,it can be desirable to determine whether the port has flipped within thebody such that the septa thereof undesirably face away from the skin atthe implantation site.

Additionally, it can be desirable to determine the number of septaincluded in an implanted port, and/or the relative orientation of thesepta. For example, it is generally desirable to determine whether aport provides fluid access to multiple lumens of a catheter operablyconnected thereto, and if so, to determine the relative orientations ofsepta associated with the lumens.

In further instances, it can be desirable to determine a functionalcharacteristic of the implanted port. For example, some embodiments ofthe port are configured to withstand relatively high pressure and flowrates typically associated with power injection of fluids through theport during relatively demanding procedures (e.g., computed tomography,or “CT,” scans), in which contrast media is rapidly infused through theport and connected catheter and into a vascular system. “Powerinjection” is defined herein to include fluid infusion under relativelyhigh flow rates and/or relatively high pressures. For instance, in oneembodiment power injection includes fluid infusion by a power injectionmachine producing fluid pressures of up to about 325 psi, resulting influid pressures in the port 10 between about 50 and about 90 psi andfluid flow through the port at a rate between about two and about fivemilliliters per second.

During power injection, a needle can be inserted in a septum of the portand connected to a power injection machine, which can introduce contrastmedia through the port at a relatively high flow rate detailed above.Certain ports may not be able to withstand pressures corresponding tohigh flow rates during power injection. Accordingly, it is oftennecessary to determine whether an implanted port is compatible for powerinjection.

With reference to FIG. 11, in one embodiment, the port 10 includes anindicator 1100 that includes radiopaque material. The indicator 1100 candefine a variety of shapes, figures, symbols, or other indicia to conveyinformation regarding a characteristic of the port 10. In someembodiments, the indicator 1100 is mounted, painted, screened on, orotherwise affixed to a bottom surface 20A primarily defined by a base 25of the port housing 20, as shown in the FIG. 11. As depicted in FIG. 11,the bottom surface 20A of the port housing 20 is defined primarily bythe base 25, and partially defined by a cap 27 that is mated with thebase during port manufacture to define the complete housing. FIG. 11further shows that the indicator 1100 is centered with respect to araised portion 25A of the base 25, though in other embodiments,placement of the indicator can vary from this configuration. Indeed, inother embodiments the indicator can be provided on another surface ofthe housing. In still other embodiments, at least a portion of theindicator can be incorporated within the housing.

In the illustrated embodiment, the indicator 1100 is an insertable pieceproduced from a radiopaque substance, such as any one or more ofsuitable metals/metal alloys. In one embodiment, the indicator 1100 isformed from a metallic material including titanium, such as titanium 64,though many other metals and other radiopaque materials could also beemployed, including stainless steel, ceramic, ceramic slurry includingceramic powder intermixed with an epoxy or resin, paintable orinjectable substances (including tungsten-filled solution), andsilk-screened products, for instance. In one embodiment, the substancefrom which the indicator piece is formed is biocompatible so as toprevent associated complications after implantation into the patient, isself-oxidizing, and is non-ferromagnetic so as to prevent imagingproblems when MRI procedures are employed. In one implementation, forinstance, the indicator piece 1100 including titanium is betweenapproximately 0.010 and about 0.020 inch thick, about 0.8 inch long, andabout 0.4 inch wide. Of course, other dimensions are possible. In oneembodiment, the insertable piece that defines the indicator 1100 isrigid before attachment to the port housing 20. In another embodiment,the indicator can be initially pliable, then solidify to rigidity eitherbefore or after attachment to the port housing.

In the illustrated embodiment, the indicator 1100 includes a firstportion 1111 and a second portion 1112. The indicator first and secondportions 1111, 1112 indicate in the present embodiment that the port 10is a dual lumen port configured for use with a dual lumen catheter.Because the indicator 1100 is radiopaque, the two portions 1111, 1112will be visible through imaging techniques, such as radiographic (x-ray)imaging. Thus, a clinician viewing a radiographic image taken of theregion of the patient in which the port 10 is implanted can see thex-ray shadow of the indicator 1100 on the image and understand that theport, by its inclusion of the two portions 1111 and 1112, includes twosepta 51, 52.

In greater detail, the indicator portions 1111 and 1112 defineequilateral triangles positioned side-by-side. Indicia 1114 are includedon the indicator first and second portions 1111, 1112 to conveyadditional information regarding the port 10. In the illustratedembodiment, the indicia 1114 include alphanumeric characters, such as“C” and “T,” defined within the triangular portions, which indicate thatthe port 10 is suitable for use with power injection. The indicia 1114included in the indicator are reversed, or backwards, when reviewed frombelow as in FIG. 11 such that the indicia will appear non-reversed whenradiographically imaged from a vantage point above the port 10. Both thefirst and second portions 1111, 1112 of the indicator 1100 include aplurality of holes 1116 defined therein so as to reduce heat sinkingwhen the indicator is heat bonded to the port base 25, as explainedfurther below.

The exploded view of the port 10 in FIG. 12A shows that the indicator1100 is sized to fit within a cavity 1120 defined on the port bottomsurface 20A, more specifically the raised portion 25A of the port base25. In one embodiment, the port base and cap 25, 27 are composed of anengineering plastic polymer material including Polyoxymethylene (“POM”),also known as an acetyl resin, and the cavity 1120 is defined as part ofthe molding process that defines the port base 25. In anotherembodiment, the cavity 1120 is defined by machining or other suitableprocess after the port base 25 has been produced. The indicator 1100 inone embodiment is attached to the port base in the cavity 1120 by heatbonding during the same ultrasonic welding process that joins the portbase 25 to the port cap 27. The holes 1116 (FIG. 11) are included in theindicator 1114 to prevent excessive heat sinking during the ultrasonicwelding process, thus ensuring an adequate attachment of the indicatorto the port base 25.

In another embodiment, the indicator can be press-fit into the cavity1120. In yet another embodiment, a combination of press-fitting andultrasonic welding can be employed to attach the indicator 1100. Ofcourse, other suitable attachment methods can also be pursued, includinginsert molding the indicator into the port base, and other materials maybe used to form the port base and cap. FIG. 12B shows the port 10 andindicator 1100 after attachment of the indicator on the bottom surface20A is complete.

The indicator described herein can indicate various characteristics ofthe multi-lumen port, including suitability of the port for powerinjectability (described above), the number or reservoirs included inthe port, and the orientation and position of the septa of the port.

FIG. 13 shows the indicator 1100 of the port 10 according to anotherembodiment, wherein each of the indicator first and second portions1111, 1112 includes a substantially circular outline 1165, 1166. Thefirst and second portions 1111, 1112 further include rounded inwardextensions 1171A, 1171B, 1171C, 1172A, 1172B, 1172C, which are intendedto convey that protrusions, such as the protrusions 71A, 71B, 71C and72A, 72B, 72C are provided on the septa 51, 52, as seen in FIG. 1. Inone embodiment, the circular outlines 1165, 1166 and the inwardextensions 1171A, 1171B, 1171C, 1172A, 1172B, 1172C correspond to anormal projection of the outer perimeter of the septa 51, 52 onto theport bottom surface 20A. The first and second portions 1111, 1112further include indicia, such as the flipped or reversed letters “C” and“T,” as shown.

FIG. 14 illustrates an image 2160 of the port 10 that can be obtained byimaging techniques, such as radiographic imaging, ultrasound imaging, orother suitable techniques. As shown, the image 2160 includes informationconveyed by the various indicator components described above, which canbe readily perceived by a clinician observing the image. For example,the indicia letters “C” and “T” indicate to the clinician that the port10 is power-injection compatible. Further, the non-reversed orientationof the imaged letters indicates that the port 10 is properly positioned,i.e., not flipped within the patient. The images of circular outlines1165, 1166 and of the inward extensions 1171A, 1171B, 1171C, 1172A,1172B, 1172C can indicate that the port 10 includes two septa 51, 52,and further helps in determining the orientation of the septa.

FIG. 15 illustrates an image 2260 that can be obtained from anotherembodiment of the port 10, wherein an indicator 2200 is shown, includingfirst portion 2211, second portion 2212, and indicia 2214A indicatingthe entity producing the port, and 2214B indicating by the letters “CT”that the port is power injectable.

FIG. 16 depicts another embodiment of an indicator 2300, including afirst portion 2311 and a second portion 2312. In contrast to previousembodiments, the first and second portions 2311, 2312 are separate fromone another.

FIG. 17 depicts another embodiment of an indicator 2400, including afirst portion 2411 and a second portion 2412. The indicator 2400 issized in the present embodiment such that the first and second portions2411, 2412 define a plurality of end points 2418, such as triangularvertices, which extend past the bottom periphery of the base 25 and arereceived into corresponding recesses 2420 defined in the portion of thebottom surface 20A defined by the cap 27. Such a configuration enablesthe indicator 2400, as a rigid piece, to be placed by itself within themold used to form the port base 25 before molding occurs, thus allowingthe port base to be molded about the indicator. Note that, though it isshown as exposed on the port bottom surface in the present embodiments,the indicator can be integrated into the port such that it is not seenupon visual inspection.

FIG. 18 depicts another embodiment of an indicator 2500 on the portbottom surface 20A. As shown, the indicator includes a lightning bolt,which can indicate, among other things, that the port 10 includes twosepta, each of which is compatible for power injection. As the port 10is often included in a kit, the kit can include instructions for userelative to the port as well as a guide for interpreting theindicator(s) of the port.

FIG. 19 depicts an example of an indicator 2600 for use with a portaccording to one embodiment, including a triangular first portion 2611and an overlapping triangular second portion 2612. Alphanumeric indicia2614A are included with each portion 2611, 2612 to indicate powerinjection compatibility, as are inward extension indicia 2614Bcorresponding to protrusions included on the septa of the port.

FIG. 20 depicts another example of an indicator 2700 for use with a portaccording to one embodiment, including a triangular first portion 2711and an overlapping triangular second portion 2712. Alphanumeric indicia2714A are included with each portion 2711, 2712 to indicate powerinjection compatibility, as are inward extension indicia 2714Bcorresponding to protrusions included on the septa of the port.

FIG. 21 depicts another example of an indicator 2800 for use with a portaccording to one embodiment, including a triangular first portion 2811and an overlapping triangular second portion 2812. Alphanumeric indicia2814A are included with each portion 2811, 2812 to indicate powerinjection compatibility, as are inward extension indicia 2814Bcorresponding to protrusions included on the septa of the port.

FIG. 22 depicts another example of an indicator 2900 for use with a portaccording to one embodiment, including a triangular first portion 2911and an overlapping triangular second portion 2912. Alphanumeric indicia2914A are included with the indicator 2900 to indicate power injectioncompatibility. Inward extension indicia 2914B are included with thefirst and second portions 2911, 2912 corresponding to protrusionsincluded on the septa of the port. A plurality of end point extensions2918 extend from the end points of the indicator portions 2911, 2912, toenable the indicator 2900, as a rigid piece, to be placed by itselfwithin the mold used to form the port base before molding occurs, thusallowing the port base to be molded about the indicator.

FIG. 23 depicts yet another embodiment of an indicator for the port 10,wherein an indicator is formed as recess 2920 on the bottom surface 20Aof the port housing 20. The recess 2920 in FIG. 23 includes a groovedefining a double triangle shape, and a recessed “C” and “T” serving asalphanumeric indicia, though in other embodiments one of a variety ofother configurations can be defined in the port. The port housing 20 inthis embodiment includes a radiopaque material, such as titanium. Othermetallic substances, alloys, or materials can also be employed. Therecess 2920 is defined on the port housing bottom surface 20A by anysuitable process, including etching, machining, molding, etc. The depthof the recess 2920 depends on the overall size and thickness of thehousing 20. In one embodiment, the recess 2920 can be filled with afiller material, such as silicone, to provide a smooth port bottomsurface 20A. Note that the recess can be defined in reverse relief towhat is shown in FIG. 23, in one embodiment. Note also that in oneembodiment, the recess 2920 can be filled with a material that is moreor less radiopaque than the material that forms the port housing 20 toprovide a contrasting radiographic image. In one embodiment, the fillermaterial can include a ceramic slurry, as already mentioned.

Because of its formation from a sufficiently thick radiopaque material,the port housing 20 itself is generally radiopaque except for relativelythinned areas of the housing. Definition of the recess 2920 thereforeprovides a relative difference in the thickness of the port 10 whenviewed from above in a radiographic image. In other words, the portionsof the recess 2920 provide a relatively thinner obstacle for x-rays topass through than relatively thicker areas of the port, resulting inless radiopacity for the recess. Thus, the image formed by the recess2920 will appear relatively lighter on a radiographic image of the port10, enabling a clinician to perceive the shape, symbols, indicia, orother elements of the indicator defined by the recess and readilydetermine an aspect of the port, its reservoirs, and/or its septa. It istherefore appreciated that an indicator as described and contemplatedherein, can serve to provide either a greater or lesser radiopacityrelative to other portions of the implantable port.

FIGS. 24A and 24B show examples of cross sectional views of an edge ofan indicator, such as the indicator 1100 shown in FIG. 12A, for example.According to example embodiments, the indicator 1100 can be die stampedor chemically etched, e.g., one or two-sided etching, from a metalsheet. In either case, depressions or protrusions, such as theprotrusions 1100A shown in FIG. 24A and 24B, can be formed as a result.When the indicator 1100 is later attached to the bottom surface of aport via ultrasonic bonding or heat staking, the protrusions 1100A caninteract with the reflowed material immediately adjacent thereto, thusanchoring the indicator to the port housing when the reflowed materialhas solidified.

Embodiments of the present invention may be embodied in other specificforms without departing from its spirit or essential characteristics.The described embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the present disclosure is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1. An implantable multi-lumen port, comprising: a housing defining atleast a first fluid reservoir and a second fluid reservoir; aneedle-penetrable first septum that provides selective access to thefirst fluid reservoir; a needle-penetrable second septum that providesselective access to the second fluid reservoir; and a set of palpationfeatures, including: a first plurality of protrusions included proximatea periphery of the first septum; and a second plurality of protrusionsincluded proximate a periphery of the second septum, the first andsecond plurality of protrusions being palpable when the port isimplanted in a patient so as to determine a characteristic of one of thefirst septum and the second septum with respect to the other septum. 2.The multi-lumen port as defined in claim 1, wherein the protrusions ofthe first plurality are defined by the housing about the first septum,and wherein the protrusions of the second plurality are defined by thehousing about the second septum.
 3. The multi-lumen port as defined inclaim 1, wherein the protrusions of the first plurality are defined bythe first septum about the periphery of the first septum, and whereinthe protrusions of the second plurality are defined by the second septumabout the periphery of the second septum.
 4. The multi-lumen port asdefined in claim 3, wherein the number of protrusions of the firstplurality equals the number of protrusions of the second plurality. 5.The multi-lumen port as defined in claim 4, wherein the first pluralityincludes three protrusions defined by the first septum, and wherein thesecond plurality includes three protrusions defined by the secondseptum.
 6. The multi-lumen port as defined in claim 5, wherein the threeprotrusions of the first plurality and the second plurality each definea vertex of an imaginary triangle.
 7. The multi-lumen port as defined inclaim 6, wherein at least one protrusion of the first plurality and thesecond plurality are positioned substantially on a long axis of theport.
 8. The multi-lumen port as defined in claim 6, wherein theimaginary triangles of the first plurality and the second plurality aremirror images of one another.
 9. The multi-lumen port as defined inclaim 1, wherein the characteristic of one of the first septum and thesecond septum with respect to the other septum is the position of thefirst septum with respect to the position of the second septum.
 10. Themulti-lumen port as defined in claim 1, wherein the characteristic ofone of the first septum and the second septum with respect to the otherseptum is the orientation of the port including the first septum and thesecond septum within the body of the patient.
 11. The multi-lumen portas defined in claim 1, wherein the protrusions of at least one of thefirst plurality and the second plurality define end points of animaginary shape selected from the group consisting of a line, atriangle, a square, a circle and a geometric shape.
 12. A multi-lumenaccess port comprising: a housing defining a first reservoir and asecond reservoir; a first septum coupled with the housing and configuredto provide selective access to the first reservoir, the first septumincluding a first plurality of protrusions defined about a periphery ofthe first septum; and a second septum coupled with the housing andconfigured to provide selective access to the second reservoir, thesecond septum including a second plurality of protrusions defined abouta periphery of the second septum, wherein the protrusions of the firstplurality and the second plurality are palpable after implantation ofthe port in a patient to determine a relative position of the firstseptum with respect to the second septum.
 13. The access port as definedin claim 12, wherein the protrusions of the first plurality and thesecond plurality each define end points of an identical imaginary shape.14. The access port as defined in claim 12, wherein each of the firstplurality and the second plurality includes three protrusions.
 15. Theaccess port as defined in claim 14, wherein the three protrusions ofeach of the first plurality and the second plurality substantiallydefine vertices of an imaginary triangle.
 16. The access port as definedin claim 15, wherein the imaginary triangles substantially defined bythe three protrusions of each of the first plurality and the secondplurality are arranged so as to be substantially bisected by a long axisof the port.
 17. The access port as defined in claim 15, wherein a topvertex of each imaginary triangle defined by the protrusions of each ofthe first plurality and the second plurality substantially lies alongthe long axis such that the imaginary triangles point toward each other.18. The access port as defined in claim 12, wherein the housing furtherdefines a palpable ridge extending between the first septum and thesecond septum.
 19. The access port as defined in claim 12, wherein theport is a dual lumen port.
 20. The access port as defined in claim 12,wherein a periphery of the protrusions of the first plurality define afirst pattern, wherein a periphery of the protrusions of the secondplurality define a second pattern, wherein protrusions of the first andsecond pluralities cooperate to produce additional patterns, each of theadditional patterns being distinct from the first and second patterns.21. The access port as defined in claim 20, wherein the first and secondpatterns are substantially the same.
 22. The access port as defined inclaim 12, wherein the protrusions are substantially hemispherical inshape.
 23. The access port as defined in claim 12, wherein theprotrusions are shaped to prevent tissue irritation when the access portis implanted in a body of a patient.
 24. The access port as defined inclaim 12, wherein the protrusions are integrally formed with therespective one of the first and second septum.
 25. A multi-lumen accessport comprising: a housing defining at least a first reservoir and asecond reservoir; a first septum coupled with the housing and configuredto provide selective access to the first reservoir; a second septumcoupled with the housing and configured to provide selective access tothe second reservoir; and an indicator that is radiographically visiblerelative to the housing, the indicator including a first portion and asecond portion, wherein the first portion includes information regardingthe first septum and first reservoir, and wherein the second portionincludes information regarding the second septum and second reservoir.26. The access port as defined in claim 25, wherein the first portionand the second portion indicate an orientation of the port afterimplantation in a patient.
 27. The access port as defined in claim 25,wherein the first portion and the second portion indicate compatibilityof the access port to power injection of fluids therethrough.
 28. Theaccess port as defined in claim 25, wherein radiographic observation ofthe indicator indicates if the access port is in a flipped orientationafter implantation in a patient.
 29. The access port as defined in claim25, wherein the housing except for the indicator is radio-translucent.30. The access port as defined in claim 25, wherein the housing includesa polymer material.
 31. The access port as defined in claim 25, whereinthe first portion is integrally formed with the second portion.
 32. Theaccess port as defined in claim 25, wherein the indicator includes arecess defined in the housing, the recess being radiographically visiblerelative to other portions of the housing.
 33. The access port asdefined in claim 32, wherein the housing includes titanium.
 34. Theaccess port as defined in claim 25, wherein the indicator includes asubstantially rigid radiopaque component that is attached to a portionof the housing.
 35. The access port as defined in claim 34, wherein theradiopaque component includes a metallic substance.
 36. The access portas defined in claim 35, wherein the radiopaque component includestitanium.
 37. The access port as defined in claim 34, wherein the firstportion and the second portion are triangularly shaped.
 38. The accessport as defined in claim 34, wherein the radiopaque component furtherincludes alphanumeric indicia with at least one of the first portion andthe second portion.
 39. The access port as defined in claim 38, whereinthe alphanumeric indicia include a letter “C” and a letter “T.”
 40. Theaccess port as defined in claim 38, wherein the alphanumeric indicia arein a reverse configuration such that the alphanumeric indicia are in anon-reverse configuration when viewed on a radiographic image.
 41. Theaccess port as defined in claim 34, wherein the radiopaque component isreceived in a cavity defined on a bottom surface of the housing.
 42. Theaccess port as defined in claim 41, wherein the radiopaque component isattached to the housing within the cavity by ultrasonic bonding.
 43. Theaccess port as defined in claim 34, wherein the bottom surface of thehousing is defined by the base and a cap joined to the base, and whereinthe radiopaque component includes at least a portion thereof thatextends beyond a periphery of the base and is received in a cavitydefined by the cap.
 44. The access port as defined in claim 34, furthercomprising a plurality of protrusions defined on the first septum andthe second septum, the protrusions being palpable after implantation ofthe dual lumen port to provide information of a position of the firstseptum relative to the second septum.
 45. The access port as defined inclaim 25, wherein the indicator provides information relating to anumber of septa included in the access port.
 46. The access port asdefined in claim 25, wherein the indicator includes a radiopacityrelatively greater than that of the housing.
 47. The access port asdefined in claim 25, wherein the indicator includes a radiopacityrelatively less than that of the housing.
 48. A method of determininginformation regarding a multi-lumen access port, the method comprising:providing a subcutaneously implanted port comprising a first septum anda second septum, the port further comprising an indicator including afirst portion and a second portion, the indicator providing informationof a characteristic of at least one of the first septum and the firstreservoir with respect to a characteristic of at least one of the secondseptum and the second reservoir; and radiographically imaging theimplanted port to form an image of the indicator.
 49. The method ofclaim 48, further comprising interpreting the image of the indicator.